Effects of Intermittent Fasting and Exercise on Inflammation, Metabolism, and the Microbiome in Metabolic Syndrome

NCT06885255 | Recruiting

• 1 other identifier: 22-60_2-B
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this intervention trial is to assess the effects of intermittent fasting, both alone and in combination with high-intensity interval training, on patients with obesity and metabolic syndrome. The main question it aims to answer is: Does intermittent fasting, with or without high-intensity interval training, reduce chronic inflammation in patients with obesity and metabolic syndrome? Participants will follow an intermittent fasting regime for 3 months, with one intervention group additionally participating in high-intensity interval training twice a week. In addition, there are two control groups: one consisting of participants with metabolic syndrome and one consisting of generally healthy individuals. The study includes a 3-month intervention phase followed by a 3-month follow-up phase. During the 6-month study period, all participants will attend 6 in-house study visits and 2 phone visits, during which they will undergo assessments and receive nutritional counseling.

Conditions

Metabolic Syndrome; Obesity and Obesity-related Medical Conditions

Keywords

obesity; metabolic syndrome; high-intensity interval training; inflammation; intermittent fasting

Outcome Measures

Primary Outcomes (1)

• hsCRP

  High sensitivity C-reactive protein in mg/l.

  From enrollment to the end of intervention at 3 months.

Secondary Outcomes (17)

• inflammatory markers and metabolic markers

  From enrollment to the end of intervention at 3 months.

• waist circumference

  From enrollment to the end of intervention at 3 months.

• fasting blood glucose

  From enrollment to the end of intervention at 3 months.

• triglycerides

  From enrollment to the end of intervention at 3 months.

• cholesterol

  From enrollment to the end of intervention at 3 months.

Study Arms (5)

Metabolic syndrome - alternate day fasting

EXPERIMENTAL

Patients with metabolic syndrome who undergo alternate-day fasting in addition to regular advice on the mediterranean diet

Other: Alternate day fasting

Metabolic syndrome - time restricted eating

EXPERIMENTAL

Patients with metabolic syndrome who undergo time restricted eating in addition to regular advice on the mediterranean diet

Other: Time restricted eating

Metabolic syndrome - time restricted eating plus high-intensity interval training

EXPERIMENTAL

Patients with metabolic syndrome who undergo time restricted eating plus high-intensity interval training in addition to regular advice on the mediterranean diet

Other: Time restricted eating; Other: High-intensity interval training

Metabolic syndrome - controls

NO INTERVENTION

Patients with metabolic syndrome exclusively receiving regular advice on the mediterranean diet

Healthy - controls

NO INTERVENTION

Healthy controls exclusively receiving regular advice on the mediterranean diet

Interventions

Alternate day fasting OTHER

Participants are instructed to alternate between consuming 100% of their usual energy intake on one day and only 25% on the following day.

Metabolic syndrome - alternate day fasting

Time restricted eating OTHER

Subjects are instructed to limit their energy intake to 8 hours a day and to fast for the remaining 16 hours.

Metabolic syndrome - time restricted eating; Metabolic syndrome - time restricted eating plus high-intensity interval training

High-intensity interval training OTHER

Patients participate in high-intensity interval training.

Metabolic syndrome - time restricted eating plus high-intensity interval training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written consent to participate in the study.
• Persons aged 18 years and older.
• Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP.

You may not qualify if:

• Pregnant or nursing individuals.
• Cardiovascular diseases or orthopedic restrictions that prevent exercise.
• Use of medication or supplements that significantly affect study outcomes (e.g., anti-inflammatory medications, antibiotics within the last 6 weeks).
• Body weight greater than 200 kg (maximum capacity of training equipment).
• Individuals with mental illnesses that may impair their ability to understand or participate in the study.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Hector-Center for Nutrition, Exercise and Sports, University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Inflammation; Intermittent Fasting

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Prof. Dr. med. Yurdagül Zopf

CONTACT

0049091318545220; yurdaguel.zopf@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Integrative Medicine with a Focus on Nutritional Medicine (W3), Director of the Hector Center for Nutrition, Exercise, and Sports

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 20, 2025
• Study Start: June 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)